BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTTRAIL REUSABLE

    MDR report key: 24744561 · Received March 31, 2026

    Report

    Report Number
    2124215-2026-17614
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 29, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    08714729939856
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. A MEDIA INSPECTION OF A PHOTO SENT BY THE CUSTOMER WAS PERFORMED. THE PHOTO DID NOT SHOW INFORMATION RELEVANT TO THE REPORTED ISSUE. THE PRODUCT RECORD REVIEW (PRR) RESULTS DETAILED IN THE PRR TABLE DID NOT DETERMINE PROBABLE CAUSE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND CONFIRMED THAT THE DEVICE MET SPECIFICATION PRIOR TO SHIPPING. NO MANUFACTURING DEVIATIONS WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE EVENT REPORTED. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF "OVERHEATING OF DEVICE OR DEVICE COMPONENT" WAS DEFINED IN THE RISK DOCUMENTATION AND IS DOCUMENTED ACCORDINGLY IN THE PRR. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. A LABELING REVIEW WAS PERFORMED ON THE DEVICE INSTRUCTIONS FOR USE (IFU). THE IFU CITED THAT RESIDUES OF BLOOD AND TISSUE AND/OR DAMAGE CAN LEAD TO OVERHEATING OF THE FIBER TIP. BASED ON THE INFORMATION AVAILABLE, THE CONCLUSION CODE "CAUSE NOT ESTABLISHED" HAS BEEN ASSIGNED AS THE MOST PROBABLE CAUSE FOR THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION, A HEATED CABLE AND A LASER OUTCOME OF A BURNT SMELL WAS NOTICED. IT WAS INDICATED THAT THE PROBLEM OCCURRED OUTSIDE THE PATIENT. THERE WAS NO REPORT OF PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION, A HEATED CABLE AND A LASER OUTCOME OF A BURNT SMELL WAS NOTICED. IT WAS INDICATED THAT THE PROBLEM OCCURRED OUTSIDE THE PATIENT. THERE WAS NO REPORT OF PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191886 LIGHTTRAIL REUSABLE POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 6463 0036592587 08714729939856

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown